Dupilumab now approved for chronic rhinosinusitis with nasal polyps in adolescents

FDA expanded the approval of dupilumab (Dupixent) to include add-on maintenance treatment of adolescents ages 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Previously, the drug was approved for this indication only in adults. Approval of the new indication was supported by evidence from the SINUS-24 and SINUS-52 trials involving adults with CRSwNP, as well as pharmacokinetic and safety data from pediatric patients with moderate to severe asthma.